Official Title
Coronavirus Disease 2019 (COVID-19) During Pregnancy: Prevalence of Seroconversion, Effect on Maternal and Perinatal Outcomes and Risk of Vertical Transmission (COVID-MAP)
Brief Summary

The objectives of this proposal are to: 1) determine the rate of SARS-CoV-2 seroconversion in unselected pregnant women in Hong Kong; 2) determine the rate of SARS-CoV-2 infection in women presenting with miscarriage and stillbirth; 3) follow the pregnancy course and perinatal outcome of confirmed COVID-19-infected pregnant cases; 4) determine the risk and characteristics of vertical transmission; and 5) evaluate the placental barrier, immune response and fetal damage in vertical transmission of SARS-CoV-2. A series of longitudinal and cross-sectional observational studies, and a laboratory-based study will be conducted to fulfil the 5 objectives.

Detailed Description

With over 10 million individuals infected worldwide, the coronavirus disease 2019 (COVID-19),
caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is a global
public health crisis. It is recognized that pregnant women are at an increased risk of
acquiring viral respiratory infection and developing severe pneumonia due to the physiologic
changes in their immune and cardiopulmonary systems. Previous studies have attempted to
determine maternal and perinatal outcome and potential risk of vertical transmission in
pregnant women affected by COVID-19, however, relevant clinical data and biological samples
have not been collected in a systematic manner. The research project will engage in
collaborative research across obstetricians/maternal-fetal medicine subspecialists,
gynecologist, infectious disease specialists, pediatrician, developmental and molecular
biologists and bioinformatician between the CUHK, China and Spain. The objectives of this
proposal are to: 1) determine the rate of SARS-CoV-2 seroconversion in unselected pregnant
women in Hong Kong; 2) determine the rate of SARS-CoV-2 infection in women presenting with
miscarriage and stillbirth; 3) follow the pregnancy course and perinatal outcome of confirmed
COVID-19-infected pregnant cases; 4) determine the risk and characteristics of vertical
transmission; and 5) evaluate the placental barrier, immune response and fetal damage in
vertical transmission of SARS-CoV-2. A series of longitudinal and cross-sectional
observational studies, and a laboratory-based study will be conducted to fulfil the 5
objectives.

Results generated will inform obstetrics and gynecology, pediatric and infectious disease
scientific communities as well as public health specialists and policy makers regarding: (1)
the estimated seroconversion rate in women of childbearing age; these results will help (i)
improve the approach to care for pregnancy and childbirth during the COVID-19 outbreak; and
(ii) formulate preventive measures to be implemented specifically for pregnant women in
reducing risk of infection and associated complications to both the women and their unborn
child; (2) the impact of COVID-19 on maternal and perinatal outcomes; data from high-quality
research will inform practice during the COVID-19 outbreak, guiding healthcare professionals
on how to adjust the management approach to infected pregnant women and the exact risks the
infection poses to the babies; (3) the risk of vertical transmission at different stages of
pregnancy and its sequelae; findings of this study will guide counselling, decision making
and clinical management; (4) the identification of cellular site of viral entry and
replication in the maternal-fetal interface that would be instrumental in designing
therapeutic measures to cease vertical transmission and developing therapeutic treatments.

Recruiting
COVID-19

Other: Non Intervention

It's an observational study, no intervention involves.

Eligibility Criteria

Objective 1: Seroconversion during pregnancy

Inclusion criteria:

- Pregnant women who attended for Down syndrome screening (DSS) at 11-13 weeks

- Had serum sample taken between 1 November 2019 and 1 June 2020 consented for stored
serum for future research

- Intended to deliver at the booking hospital.

Objective 2: SARS-CoV-2 and pregnancy loss

Inclusion criteria:

•Pregnant women presenting with first and second trimester miscarriage in Hong Kong and
Spain, as well as those with stillbirth during periods of 6 and 12 months, respectively.

Objective 3: Pregnancy course and perinatal outcome

Inclusion criteria:

•Pregnant women affected by COVID-19

Objective 4: Vertical transmission

Inclusion criteria:

•Pregnant women affected by COVID-19

Objective 5: Potential mechanisms for vertical transmission

Inclusion criteria:

•Pregnant women affected by COVID-19

Eligibility Gender
Female
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
China
Hong Kong
Spain
Locations

Peking University First Hospital
Beijing, Beijing, China

Kwong Wah Hospital
Hong Kong, Hong Kong

Pamela Youde Nethersole Eastern Hospital
Hong Kong, Hong Kong

Princess Margaret Hospital
Hong Kong, Hong Kong

Queen Elizabeth Hospital
Hong Kong, Hong Kong

Queen Mary Hospital
Hong Kong, Hong Kong

The Chinese University of Hong Kong, Prince of Wales Hospital
Hong Kong, Hong Kong

Tuen Mun Hospital
Hong Kong, Hong Kong

United Christian Hospital
Hong Kong, Hong Kong

Hospital Universitario de Torrejón
Torrejón De Ardoz, Madrid, Spain

Contacts

Liona POON
(852) 3505 2582
liona.poon@cuhk.edu.hk

Equal CHEN
(852) 3505 1536
equalchen@cuhk.edu.hk

Chinese University of Hong Kong
NCT Number
Keywords
pregnancy
Vertical transmission
pregnancy loss
ACE2 TMPRSS2
MeSH Terms
COVID-19